Zimmer Biomet Recalls Humeral Guide Wires Due to Sterile Packaging Seal Failure
Zimmer Biomet is recalling 19,483 M/DN Intramedullary Fixation Humeral Guide Wires because of a potential failure of the sterile packaging seal.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a potential sterile packaging seal failure. No illnesses or injuries are reported in the source text, and the risk is theoretical, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 19,483 units of the M/DN Intramedullary Fixation Humeral Guide Wire, Bullet Tip, 2.4 mm Diameter, 70 cm Length (Item Number: 00-2255-026-00). The recall is due to a potential failure of the sterile packaging seal.
The affected products were distributed nationwide in the United States and in Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, the Netherlands, and Trinidad. The specific lot numbers involved are 63733046, 63758426, and 77006554.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected guide wires. The source text does not provide specific instructions for disposal or return, so facilities should follow their standard protocols for handling recalled medical devices or contact the manufacturer for guidance.
The recalled product
- Product
- M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter, 70 cm Length; Item Number: 00-2255-026-00
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 19,483
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 63733046 63758426 77006554
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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